UDI Reference Center

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EUDAMED

Global UDI

GUDID

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GUDID Reference Center

Be ready for Class l device registration by December 2022

FDA’s GUDID compliance deadline for Class I medical devices, December 8, 2022 is just around the corner! Time certainly flies – and even with the postponement of the FDA’s enforcement data for UDI labeling and GUDID data submission requirements for Class I and unclassified devices – you must be on the ball in preparing for December 2022! How is your company preparing to aggregate, validate and submit your regulatory data for your Class I medical devices? Innovit have you covered, with all the information and tools you require today, to meet evolving Unique Device Identifier (UDI) and GUDID compliance. So bookmark this page as your launch pad to find everything you ‘need to know’ about GUDID and your quest for compliance.

What is
GUDID

The Global Unique Device Identification Database (GUDID) is a system administered by the FDA that will serve as a reference catalog for every medical device.

FAQ – GUDID
Device Registration

Your answers for registering devices on the FDA’s Unique Device Identification (UDI) system.

GUDID
playground

Your very own playground environment to gather, validate and test the submission of device registration data for GUDID compliance.

FDA GUDID Technical
Documentation

Download you Technical Specifications, Business Rules & guids for preparing your product master data for GUDID submission

 

FDA UDI Regulations
Documents & Guidance

Read the latest communications and guidance from FDA regarding UDI regulations and GUDID data compliance.